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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to valid methods and considered reliable, adequate and relevant. Limited details were available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic Toxicity Studies on Two Epoxidized Soybean Oils in the Rat and Dog.
- Author:
- Larson P.S., Finnegan J.K., Haag H.B., Blackwell Smith Jr. R. and Hennggar Gordan R.
- Year:
- 1 960
- Bibliographic source:
- Toxicology and Applied Pharmacology 2, 649-658
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Soybean oil, epoxidized
- EC Number:
- 232-391-0
- EC Name:
- Soybean oil, epoxidized
- Cas Number:
- 8013-07-8
- IUPAC Name:
- 8013-07-8
- Details on test material:
- - Name of test material (as cited in study report): Paraplex G-62 and Paraplex G-60 (two epoxidized Soybean Oils)
- Substance type: UVCB
- Physical state: no data
- Analytical purity: no data
- Other: Supplied by the Rohm and Haas Company, Philadelphia, Pennsylvania
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: young albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not provided
- Age at study initiation: young
- Housing: . The rats were individually caged.
- Diet (e.g. ad libitum): Finely ground Purina Dog Chow Kibbled Meal served as the basic diet
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Finely ground Purina Dog Chow Kibbled Meal as basic diet
- Details on oral exposure:
- - Mixing appropriate amounts with (Type of food): Finely ground Purina Dog Chow Kibbled Meal served as the basic diet, and into this was incorporated amounts of Paraplex G-60 calculated to achieve the dietary concentrations of 0, 0.1, 0.5, 1.0, 2.5, and 5.0%.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Estimate of the effective concentration by analysis of regression of the data with 95 % confidence limits
- Duration of treatment / exposure:
- 1 year continuous for the subgroups with 5 M/F per group.
2 years ciontinuous for the subgroups with 10 M/F per group. - Frequency of treatment:
- daily in food
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.1, 0.5, 1.0, 2.5, and 5.0%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15: Each group of 15 was subdivided into subgroups of 10 and 5 animals. At the end of one year, the survivors in the subgroups of 5 were sacrificed for histopathologic studies; organ to body weight measurements were made for liver, kidney, and testes. The subgroups of 10 were continued on diet for a second year.
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: The rats were weighed once weekly.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): no
HAEMATOLOGY: Yes
- Time schedule for collection of blood:
Paraplex G-60: Blood studies (hemoglobin, red blood cell, and differential white cell counts) were made during the eleventh and twenty-fourth months.
Paraplex G-62: Hematologic studies were made at 6 as well as at 12 and 24 months
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: subgroups of 10
- Parameters examined: hemoglobin, red blood cell, and differential white cell counts
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY:
No data
HISTOPATHOLOGY: Yes.
-Paraplex G-60: At the end of one year, the survivors in the subgroups of 5 were sacrificed for histopathologic studies; organ to body weight measurements were made for liver, kidney, and testes. Histopathologic studies were made on two-year survivors from the 0, 2.5, and 5.0% diets.
-Paraplex G-62: : At the end of 6 months, the survivors in the subgroups of 5 were sacrificed for histopathologic studies; organ to body weight measurements were made for liver, kidney, and testes. Histopathologic studies were made on two-year survivors from the 0, 2.5, and 5.0% diets. - Statistics:
- Estimate of the effective concentration, liver ratio and kidney ratio by analysis of regression of the data with 95 % confidence limits.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No definite effect on survival is apparent.
- Mortality:
- no mortality observed
- Description (incidence):
- No definite effect on survival is apparent.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- see details on results
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- see details on results
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- no lesions attributable to treatment
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No definite effect on survival is apparent.
BODY WEIGHT AND WEIGHT GAIN
-Paraplex G-60: In both sexes there was early depression of growth at the 5% dietary level (P = < 0.05 at 2 and 4 weeks); this was followed by accelerated growth.
-Paraplex G-62: Among female rats, growth was significantly depressed during the early period on the diet. Analysis of regression of the data (linear at 2 and 8 weeks; curvilinear being required by the data at 4 weeks) with 95% confidence limits indicated the effective concentration to be about 3.75% at 2 weeks and 1.0% at 4 weeks, followed by no significant depression by 8 weeks. Among male rats, growth was also depressed during the early period. Analysis of linear regression of the data with 95 % confidence limits indicated the effective concentration to be about 2.1% at 2 weeks, 1.6% at 4 weeks, and 3.7% at 8 weeks, after which the effect gradually disappeared.
HAEMATOLOGY
-Paraplex G-60: Hematologic values were within normal limits at all dietary level.
-Paraplex G-62: Hematologic values were within normal limits at each examination.
ORGAN WEIGHTS
-Paraplex G-60: Male rats receiving the 5% diet had significantly elevated liver to body weight ratios.
-Paraplex G-62: Analysis of regression of the liver ratio data ( curvilinear for females, linear for males) with 95 % confidence limits indicate that significantly elevated ratios result from the treatment and that the effective concentration should fall at 0.5% for females and 2.3% for males. Similar statistical treatment of the kidney ratio data indicates the occurrence of significantly elevated ratios from the treatment for females only and that the effective concentration should fall at 1.6%.
HISTOPATHOLOGY: NON-NEOPLASTIC
-Paraplex G-60: Histopathologic studies on heart, lung, liver. kidney, spleen, gastroenteric, thyroid, adrenal pancreas, gonad. muscle, and bone marrow tissues of the rats at one and two years on the diet showed no lesions attributable to treatment.
-Paraplex G-62: Histopathologic studies made on the same tissues as listed above for Paraplex G-60 showed no lesions attributable to treatment.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 1 other: % nominal in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: liver & kidney
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
-Paraplex G-60
Fifteen young male and 15 female albino rats were placed on each of the following dietary levels of the test material: 0, 0.1, 0.5, 1.0, 2.5, and 5.0%. Finely ground Purina Dog Chow Kibbled Meal served as the basic diet, and into this was incorporated amounts of Paraplex G-60 calculated to achieve the above dietary concentrations. The rats were individually caged and were weighed once weekly. Each group of 15 was subdivided into subgroups of 10 and 5 animals. At the end of one year, the survivors in the subgroups of 5 were sacrificed for histopathologic studies; organ to body weight measurements were made for liver, kidney, and testes. The subgroups of 10 were continued on diet for a second year. Blood studies (hemoglobin, red blood cell, and differential white cell counts) were made during the eleventh and twenty-fourth months.
Histopathologic studies were made on two-year survivors from the 0, 2.5, and 5.0% diets.
-Paraplex G-62
This study on rats was identical in all respects to that described above for Paraplex G-60 except that the rat subgroups of 5 were sacrificed at the end of 6 months and hematologic studies were made at 6 as well as at 12 and 24 months.
Applicant's summary and conclusion
- Conclusions:
- Two epoxidized soybean oils, Paraplex G-60 and Paraplex G-62, were added to the diets of rats for a two-year period in concentrations up to 5%. No effects were observed on survival or on the blood picture and histologic examination of tissues revealed no lesions attributable to treatment. Early depression in growth was observed in rats from both materials (Paraplex G-62 being the most potent), but this effect disappeared on continued feeding.
Elevated liver to body weight ratios resulted at the 5% concentration in male rats receiving Paraplex G-60 and at lower concentrations in both male and female rats receiving Paraplex G-62; kidney to body weight ratios were also elevated with the latter material in female rats. - Executive summary:
Two epoxidized soybean oils, Paraplex G-60 and Paraplex G-62, were added to the diets of rats for a two-year period in concentrations up to 5%. Groups of rats (15/sex) were given diets containing 0, 0.1, 0.5, 2.5 or 5% (up to approximately 1250 mg/kg bw) ESBO for up to 2 years. Five rats/sex/group were sacrificed at 6 months. Organ to body weight measurements were made for liver, kidney and testes. Blood studies (hemoglobin, red blood cell and differential white cell counts) were made during the eleventh and twenty-fourth months. Histopathology of heart, lung, kidney, spleen, gastroenteric, thyroid, adrenal, pancreas, gonad, muscle and bone marrow tissues was conducted on survivors from the 0, 2.5% and 5% diet groups. Growth appeared to be essentially normal at 2.5%, but appeared to be permanently low in the 5% group. A limited evaluation of the blood (red blood cell and white blood cell counts) revealed no effects. Liver weight was increased in both sexes at 1% and above. There was some evidence that kidney weight was increased in the females at 1% and above.
Microscopic examination of the major tissues revealed no cellular changes at 2.5% or 5% (only dose groups examined). In conclusion, Lowest Adverse Effect Level (LOAEL) was 1% in the diet (approximately 250 mg/kg bw).
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